Jardiance® (empagliflozin) now approved in India for the treatment of adults with chronic kidney disease

The national regulatory authority of India, Central Drugs Standard Control Organisation (CDSCO), has approved Jardiance^® (empagliflozin) 10mg tablets to reduce the risk of sustained decline in eGFR (only for patients with eGFR 30-90 ml/min/1.73m²), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. This indication approval allows nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in eligible patients. It should be noted that Jardiance is not recommended for the treatment of CKD in patients with polycystic kidney disease, or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease.

The approval has the potential to advance the standard of care for an estimated >33 million adults in India living with CKD⁵ and help relieve the burden on healthcare systems by reducing the risk of hospitalizations, as well as delaying progression to kidney-failure, for people with CKD. 

“Chronic kidney disease is an important health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Gagandeep Singh Bedi, Managing Director, Boehringer Ingelheim India. “We are very excited about the approval and the potential for empagliflozin to play an essential role in helping people living with kidney disease and their physicians. It also underscores our commitment to bringing innovative solutions that address the unmet medical needs in India.”

Dr. Shraddha Bhure, Medical Director, Boehringer Ingelheim India, emphasized the significance of this development. “CKD is a major health problem in India, arising from common risk-factors like diabetes, hypertension, or cardiovascular disease, to name a few. Patients with CKD progression are at increased risk of hospital-admissions, cardiac events, kidney-failure, and death. Apart from the impact on health, a large proportion of patients with CKD also need to face catastrophic health-expenditure. The prognosis of CKD may vary according to different underlying causes and/or stages of CKD; this may necessitate proven treatment-options for different patients with CKD. The scientific evidence with empagliflozin, on providing clinically meaningful improvement in CKD outcomes across a broad range of eligible patients, provides compelling reasons to improve the current treatment-landscape of CKD. Optimum management of CKD can foster substantial improvements in health and economic outcomes, for not only patients and their families, but also the society and the country’s healthcare system at large.”

Padma Shri Dr. (Prof.) Kamlakar Tripathi has quoted, “Chronic kidney disease has been recognized as a priority in our country’s national program for non-communicable diseases. In the early stages, chronic kidney disease often progresses without overt clinical symptoms, which often leads to delay in the diagnosis. Patients who are diagnosed with advanced chronic kidney disease are at much greater risk of major events like hospitalizations, kidney failure, and cardiovascular death. A key aspect of optimum kidney care is early detection and slowing the progression of chronic kidney disease. An early intervention can retard the progression towards end-stage kidney disease.”

“People with diabetes, high blood-pressure, cardiovascular disease and family history of kidney disease, are some individuals who have a high risk for developing chronic kidney disease. It is essential that these individuals get regularly tested for chronic kidney disease and receive appropriate treatment for optimum kidney protection. It is heartening that good scientific research, like the EMPA-KIDNEY study, is yielding promising treatment options that can serve more diverse groups of eligible patients with chronic kidney disease,” added Dr. Tripathi.

About EMPA-KIDNEY Study

EMPA-KIDNEY (NCT03594110) is a multinational randomized, double-blind, placebo-controlled clinical trial, designed to evaluate the effect of Jardiance (empagliflozin) on kidney disease progression and cardiovascular mortality risk. EMPA-KIDNEY is the largest and broadest dedicated trial of a sodium-glucose cotransporter-2 (SGLT2) inhibitor in CKD to date. The study included 6,609 adults with CKD at risk of progression, across a broad range of underlying causes with and without diabetes, as well as different stages of CKD with and without albuminuria. Patients were excluded if they had both type 2 diabetes and prior atherosclerotic cardiovascular disease with eGFR above 60 mL/min/1.73m², had type 1 diabetes, had a functioning or scheduled kidney transplant, were on dialysis, had polycystic kidney disease, or required or had a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease. The patients received either Jardiance 10mg once daily or placebo, on top of current standard of care. Jardiance significantly reduced the relative risk of kidney disease progression or cardiovascular death in adults with CKD by 28% compared with placebo, both on top of standard of care. EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to show a significant reduction in risk of hospitalization for any cause, with a 14% relative risk reduction with Jardiance versus placebo, both on top of standard of care. Overall, the safety data in EMPA-KIDNEY were consistent with the previously known safety profile of Jardiance.

About chronic kidney disease

Chronic kidney disease affects approximately 850 million people worldwide which is more than 10% of the population. The condition is caused by progressive damage to the kidneys that prevents them from working as well as they should. With it mostly being asymptomatic (no symptoms) until later stages of the condition, most people go undiagnosed and every year millions die prematurely from chronic kidney disease and related complications. Boehringer Ingelheim is committed to transforming care for people with chronic kidney disease, as well as other cardio-renal-metabolic conditions.

About empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter-2 (SGLT2) inhibitor.

About Boehringer Ingelheim 

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.in.

Disclaimer: It should be noted that the information contained in this press-announcement is not intended to serve as a medical opinion or advice for the treatment of chronic kidney disease. The treatment decisions for chronic kidney disease, must be based on the clinical advice from appropriate medical professionals.